A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt (CICOM1010)

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Dr. David Yan, DBYAN Medicine Professional Corporation
ClinicalTrials.gov Identifier:
NCT00621335
First received: February 13, 2008
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

The objective of this research study is to compare the tolerability and effectiveness of Combigan(brimonidine tartrate/timolol maleate) and Cosopt (dorzolamide hydrochloride)in the treatment of open angle glaucoma or ocular hypertension.


Condition
Open Angle Glaucoma
Ocular Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A 12- Week Investigator Masked, Parallel Comparison of Tolerability of Combigan and Cosopt in the Treatment of Open Angle Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by DBYAN Medicine Professional Corporation:

Primary Outcome Measures:
  • Comparison of the tolerability and effectiveness of Combigan and Cosopt in the treatment of open angle glaucoma or ocular hypertension [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: March 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Detailed Description:

Patients between the ages of 40 to 90 years of age, that have been diagnosed with open angle glaucoma or ocular hypertension,including pseudo-exfoliation and pigmentary glaucoma with definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss, who have been receiving a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination are to be included in the study.Patients must have an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline.

Patients with any other form of glaucoma other than primary open angle glaucoma, with a gonioscopy measured angle grade of less than 2, with a visual field defect not of glaucomatous origen and previous cyclodestructive procedures will be excluded.The use of ocular non steroidal and anti-inflammatory topical agents which inhibit cyclooxygenase and prostaglandin analog synthesis,the use of glucocorticoid therapy, and hypersensitivity to any of the study components also precludes involvement in the study. Any ocular laser therapy within the past three months, ocular inflammation or infection in the past three months or any history of trauma in the last six months will also exclude enrollment in the study.

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • open angle glaucoma or ocular hypertension including pseudo-exfoliation and pigmentary glaucoma
  • definitive glaucomatous optic disk cupping and/or glaucomatous visual field loss
  • a stable treatment regime for at least 4 weeks prior to the study initiation, with a Cosopt mono or a Prostaglandin + Cosopt combination
  • an IOP between 16 and 32 mmHg, with no readings above 35 mmHg at baseline

Exclusion Criteria:

  • any other form of glaucoma other than primary open angle glaucoma
  • a gonioscopy measured angle grade of less than 2
  • a visual field defect not of glaucomatous origen
  • previous history of cyclodestructive procedures
  • the use of ocular non steroidal and anti-inflammatory topical agent that inhibit cyclooxygenase and prostaglandin analog synthesis
  • the use of glucocorticoid therapy
  • hypersensitivity to any of the study components
  • any ocular laser therapy within the past three months
  • ocular inflammation or infection in the past three months
  • any history of trauma in the last six months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621335

Locations
Canada, Ontario
Ophthalmic Consultants Centres
Mississauga, Ontario, Canada, L4W 1W9
Sponsors and Collaborators
DBYAN Medicine Professional Corporation
Allergan
Investigators
Principal Investigator: David Yan, M.D. University of Toronto
  More Information

No publications provided

Responsible Party: Dr. David Yan, Dr. David Yan M.D, F.R.C.S (c), DBYAN Medicine Professional Corporation
ClinicalTrials.gov Identifier: NCT00621335     History of Changes
Other Study ID Numbers: CICOM 1010
Study First Received: February 13, 2008
Last Updated: February 22, 2013
Health Authority: Canada: Health Canada

Keywords provided by DBYAN Medicine Professional Corporation:
Open angle glaucoma
Ocular hypertension
Parallel comparison
Combigan
Cosopt

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014